MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAD-97 W/CAPNOGRAPHY; OXIMETER

Model Number	27576
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted.
Event or Problem Description
The customer reported that the rad-97 turned off during use and would not turn back on.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.External visual inspection found no defects or damage.Unit doesn't power on using ac or dc power.Internal inspection found the fuse f1 on the connectivity board circuit board had open circuited, preventing the unit from powering on.The battery had 0v.After temporarily shorting the open fuse f1 on the device, the battery was able to be charged.The unit then powered on and was functioning as designed.A service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues related to this reported event.
Event or Problem Description
The customer reported that the rad-97 turned off during use and would not turn back on.No consequences or impact to patient were reported.

• Brand Name: RAD-97 W/CAPNOGRAPHY
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 12100736
• Report Number: 3011353843-2021-00153
• Device Sequence Number: 11717354
• Product Code: MWI
• UDI-Device Identifier: 00843997012782
• UDI-Public: 00843997012782
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27576
• Device Catalogue Number: 9799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1